# K982917: B-System Silicone

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Oct 16, 1998 after 58 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Heraeus Kulzer, Inc., CutterSil® Polysiloxane Impression Materials: named in the summary without a submission number

## Indications for use
B-System Silicone is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

Source page: https://510kreport.com/device/K982917
Methodology: https://510kreport.com/methodology